Bristol-myers Squibb Company · NYSE:BMY
Bristol-myers Squibb — Q3 2023 Earnings Presentation
56 slides from Bristol-myers Squibb's earnings presentation, Oct 26, 2023
Slide 1: Q3 2023 Results
Q3 2023 Results October 26, 2023
Slide 2: Forward Looking Statements and Non-GAAP Financial Information
Forward Looking Statements and Non-GAAP Financial Information This presentation contains statements about Bristol-Myers Squibb Company’s (the “Company”) future financial results, plans, business development strategy, anticipated clinical trials, results and regulatory approvals that constitute forwa
Slide 3: Giovanni Caforio, MD
Q3 2023 Results Giovanni Caforio, MD Board Chair and Chief Executive Officer 3
Slide 4: Chris Boerner, PhD
Q3 2023 Results Chris Boerner, PhD Chief Operating Officer Chief Executive Officer, effective November 1, 2023 4
Slide 5: Q3 2023 Performance
Q3 2023 Performance Q3 Global Net Sales Medium-Term Financial Targets* • 11.0B; (2%) YoY; (3%) Ex-FX* Reaffirms1: • Low-to-mid single digit revenue CAGR2 Commercial In-Line Brands & New Product Portfolio • Low double-digit revenue CAGR2 ex-Rev/Pom Financial & Financial • ~$9.3B; +8% YoY; +7% Ex-FX*
Slide 6: Our Goal is to Deliver Sustainable Growth
Our Goal is to Deliver Sustainable Growth Four Key Enablers Evolve R&D for Strong commercial Execute strategic Foster a high- scientific leadership execution to realize capital allocation to performance culture value of our further strengthen and attract & retain marketed portfolio our growth profil
Slide 7: Solid Momentum in Q3 & Accelerating Future Growth
Solid Momentum in Q3 & Accelerating Future Growth Key In-Line Products New Product Portfolio Outlook* $ in millions +67% ex-FX* $928 • Expect >$10B revenue $29 $43 from new product $66 portfolio in 2026 • Strong U.S. demand $68 growth offset by gross- $92 to-net adjustments $553 ** • Focused on prod
Slide 8: Strong Delivery from our R&D Engine Since R&D Day
Strong Delivery from our R&D Engine Since R&D Day Oncology Immunology Hematology Opdivo LPA1 antagonist Reblozyl ‒ U.S. approval in Stage II ‒ Breakthrough Therapy ‒ U.S. approval in 1L MDS adj. melanoma Designation granted in PPF associated anemia with a ‒ Peri-adj. lung & 1L MIUC broad label prese
Slide 9: Mirati Therapeutics: Strong Strategic Fit
Mirati Therapeutics: Strong Strategic Fit Extending in IO • Best-in-class KRASG12C inhibitor approved in 2L+ mutated NSCLC; confirmatory Ph3 results expected 1H 2024 • Potential KRASG12C mutated tumor opportunities: 1L NSCLC; 2L & 3L+ CRC Indication Development Status TPS ≥ 50%: Krazati + pembrolizu
Slide 10: Continued Strong Pipeline Execution
Continued Strong Pipeline Execution 2023 Key Milestones 2024/2025 Key Milestones Initiation of pivotal Metastatic: 1L MF Ph3 Early Stage: Reblozyl post-transplant 1L HCC Ph3 (CM-9DW) (INDEPENDENCE) Neo-adjuvant NSCLC Ph3 iberdomide Opdivo maintenance H2H vs 1L+ MSI High CRC Ph3 (CM-816) ap
Slide 11: Numerous Levers to Drive Long-Term Growth
Numerous Levers to Drive Long-Term Growth Extended durability of our IO business with subcutaneous nivolumab and Opdualag Increasingly de-risked the New Product Portfolio Number of registrational assets increasing from 6 to 12 over the next 18 months Developing medicines in rapidly growing markets w
Slide 12: David Elkins
Q3 2023 Results David Elkins Executive Vice President and Chief Financial Officer 12
Slide 13: Total Company Performance Driven by In-Line & New Product Portfolios
Total Company Performance Driven by In-Line & New Product Portfolios Total Company Sales ~$11B (2%) YoY, (3%) Ex-FX* $B Q3 Net Sales1 YoY % Ex-FX* % $1.7 Total Company $11.0 (2%) (3%) $2.6 In-Line Products $8.3 +3% +3% New Product $0.9 +68% +67% $9.3 Portfolio $8.6 In-Line Products & $9.3 +8% +7% Ne
Slide 14: New Product Portfolio Performance
New Product Portfolio Performance Building strong momentum for future growth +67% growth vs PY Ex-FX* $ in millions $ in millions $928 $29 $2,513 $43 $66 $68 $92 ** $553 $93 $21 $1,385 $1 $32 $5 $44 $123 $107 $166 $730 $69 $84 $248 $190 YTD 2021 YTD 2022 YTD 2023 Q3 2022 Q3 2023 Reblozyl Opdualag Ze
Slide 15: Q3 2023 Oncology Product Summary
Q3 2023 Oncology Product Summary Q3 Global Net Sales Opdivo: • U.S. YoY volume growth in 1L lung, upper GI & adj. $M YoY % Ex-FX* % bladder cancer • Ex-U.S. YoY growth of +15% ex-FX* primarily from $2,275 +11% +11% demand in 1L lung & upper GI & expanded access Opdualag: $579 +11% +10% • U.S. growth
Slide 16: Q3 2023 Cardiovascular Product Summary
Q3 2023 Cardiovascular Product Summary Q3 Global Net Sales $M YoY % Ex-FX* % $M YoY % Ex-FX* % $2,705 +2% - $68 ** ** Best-in-class & leading OAC within category First-in-class myosin inhibitor Eliquis: • U.S. increase in total treated & commercial dispensed patients • U.S. growth driven by strong u
Slide 17: Q3 2023 Hematology Product Summary
Q3 2023 Hematology Product Summary Q3 Global Net Sales1 Revlimid: FY 2023 revenue projection ~$6.0B 1 $M YoY % Ex-FX* % Reblozyl: $1,429 (41%) (41%) • U.S. FDA approval in August 2023 in 1L MDS-associated anemia with a broad label (COMMANDS) $872 (2%) (2%) • U.S. strong YoY growth of +28% driven by
Slide 18: Q3 2023 Immunology Product Summary
Q3 2023 Immunology Product Summary Q3 Global Net Sales % $M YoY % Ex-FX* % % $M YoY % Ex-FX* % $925 +5% +5% $66 ** ** $123 +78% +75% First-in-class selective allosteric TYK2 inhibitor • U.S. continued volume growth; ~$30M clinical purchase in quarter Zeposia: • Progress converting patients on CVS in
Slide 19: Q3 2023 Financial Performance
Q3 2023 Financial Performance US US GAAP GAAP Non-GAAP Non-GAAP * $ in billions, except EPS Q3 2023 Q3 2022 Q3 2023 Q3 2022 Total Revenues, net 11.0 11.2 11.0 11.2 Gross Margin % 77.1% 79.0% 77.3% 79.8% Operating Expenses1 4.2 4.3 4.1 4.1 Acquired IPR&D 0.1 - 0.1 - Amortization of Acquired Intangibl
Slide 20: Balanced Approach to Capital Allocation
Balanced Approach to Capital Allocation Cash flow from Operations $B $4.8 • Prioritize opportunities to further diversify portfolio & strengthen long-term outlook Business $3.7 Development ‒ Entered into agreement to acquire Mirati Therapeutics; planned close by 1H 2024 $3.3 $3.0 $1.9 Balance Sheet
Slide 21: Revised 2023 Guidance
Revised 2023 Guidance US GAAP* Non-GAAP* July (Prior) October (Revised) July (Prior) October (Revised) Total Revenues Low-single digit decline No Change Low-single digit decline No Change Reported Rates Total Revenues Low-single digit decline No Change Low-single digit decline No Change Ex-FX Revlim
Slide 22: Medium-Term Guidance
Medium-Term Guidance* July 2023 October 2023 • Low-to-mid single-digit revenue CAGR1 from • Reaffirms low-to-mid single-digit revenue CAGR1 2020-2025 from 2020-2025 • Low double-digit revenue CAGR1 ex-Rev/Pom • Reaffirms low double-digit revenue CAGR1 ex- from 2020-2025 Rev/Pom from 2020-2025 • $8B-
Slide 23: Q3 2023 Results Q&A
Q3 2023 Results Q&A Giovanni Caforio, MD Chris Boerner, PhD David Elkins Samit Hirawat, MD Adam Lenkowsky Board Chair, Executive VP, Executive VP, Executive VP, Executive VP, Chief Executive Officer Chief Operating Officer, Chief Financial Officer Chief Medical Officer, Chief Commercialization Offic
Slide 24: Bristol Myers Squibb Company Reconciliation of Certain GAAP Line Items to Certain Non-GAAP Line Items
Bristol Myers Squibb Company Reconciliation of Certain GAAP Line Items to Certain Non-GAAP Line Items (Unaudited, dollars in millions) Year-Ended December 31 2020 2021 2022 Total Revenues $42,518 $46,385 $46,159 Gross Profit $30,745 $36,445 $36,022 Specified items (a) $3,300 $603 $356 Gross Profit e
Slide 25: 2023 Key News Flow
2023 Key News Flow Asset Timing Asset Timing Opdivo Reblozyl EU approval in Neo-Adj. Lung EFS EU Approval June 2023 EU approval in NTD Beta-Thalassemia EU Approval March 2023 (CM-816) Associated Anemia Opdivo Reblozyl Presented at ASCO & EHA 2023 Study Discontinued1 1L TD MDS Associated Anemia U.S.
Slide 26: Q3 2023 Opdivo Sales Mix
Q3 2023 Opdivo Sales Mix U.S. Sales Mix Ex-U.S. Sales Mix 11% 24% 21% 29% 24% 18% 21% 7% 20% 25% Q3 2023 Results Note: percentages are approximate Not for Product Promotional Use 26
Slide 27: Q3 2023 Eliquis NBRx/TRx Share
Q3 2023 Eliquis NBRx/TRx Share NBRx Share – US TRx Share - US 24% 21% 25% 23% 10% 9% 15% 13% 67% 70% 64% 60% Q3 2022 Q3 2023 Q3 2022 Q3 2023 Eliquis Warfarin Other NOACs Q3 2023 Results Rx Source: IQVIA Not for Product Promotional Use 27
Slide 28: Our ESG updates and looking ahead
Our ESG updates and looking ahead ESG Materiality Assessment Results 2022 ESG Report Completed a global, double ESG materiality assessment1 and identified the On August 23, 2023, published BMS’ 2022 ESG 8 ESG factors that were rated as most “material” by stakeholders Report,2 providing increased
Slide 29: Clinical Development Portfolio – Phase I and II
Clinical Development Portfolio – Phase I and II Data as of October 26th, 2023 Phase I Phase II AHR Antagonist*^ Solid Tumors Solid Tumors Anti-CCR8^ Solid Tumors Anti-CTLA-4 NF Probody® Therapeutic Lung Cancer Anti-ILT4^ Solid Tumors Colorectal Cancer AR LDD 1L, 2L Metastatic Castration-Re
Slide 30: Clinical Development Portfolio – Phase III
Clinical Development Portfolio – Phase III Data as of October 26th, 2023 Phase III Registration US, EU, JP Adjuvant Hepatocellular Carcinoma repotrectinib ROS1 NSCLC (US, JP) Peri-adjuvant Muscle-Invasive Urothelial Carcinoma ABECMA 3-5L Multiple Myeloma (US, EU, JP) OPDIVO Peri-adjuvant Non-Small C
Slide 31: Q3 2023 Late-Stage Drug Development Clinical Trials Update
Q3 2023 Late-Stage Drug Development Clinical Trials Update Oncology Hematology Cell Therapy Immunology Cardiovascular Opdivo iberdomide Breyanzi cendakimab milvexian Opdualag mezigdomide Abecma LPA1 antagonist Camzyos repotrectinib Reblozyl Sotyktu Onureg Zeposia alnuctamab obexelimab Q3 2023 Result
Slide 32: Opdivo (anti-PD1)
Oncology Hematology Cell Therapy Immunology Cardiovascular Opdivo (anti-PD1) Lung Cancer Trials Indication Peri-Adjuvant NSCLC Stage IB-IIIA Adjuvant NSCLC Stage III Unresectable NSCLC Phase III – ANVIL Phase III - CheckMate -73L Phase/Study Phase III – CheckMate -77T Non-BMS Sponsored* # of Patient
Slide 33: Opdivo (anti-PD1)
Oncology Hematology Cell Therapy Immunology Cardiovascular Opdivo (anti-PD1) Early-Stage Trials Indication Peri-Adjuvant MIUC Adjuvant HCC Phase/Study Phase III - CA 017-078 Phase III – CheckMate -9DX # of Patients N = 861 N = 545 • Opdivo 360 mg Q3W for four cycles + chemotherapy • Opdivo 480 mg Q4
Slide 34: Opdivo (anti-PD1)
Oncology Hematology Cell Therapy Immunology Cardiovascular Opdivo (anti-PD1) Metastatic Trials Indication 1L HCC 1L+ MSI High CRC Phase/Study Phase III – CheckMate -9DW Phase III - CheckMate -8HW # of Patients N = 732 N = 831 • Opdivo + Yervoy • Opdivo (Arm A) Design • sorafenib/lenvatinib • Opdivo
Slide 35: Opdivo (anti-PD1)
Oncology Hematology Cell Therapy Immunology Cardiovascular Opdivo (anti-PD1) Metastatic Trials Indication 1L MIUC 2L RCC SC Phase/Study Phase III - CheckMate -901 Phase III - CheckMate -67T # of Patients N = 1,290 N = 454 • PD-L1+ & cis-ineligible: Opdivo 1 mg/kg + Yervoy 3 mg/kg Q3W up to • Opdivo
Slide 36: Opdualag (anti-LAG3 + anti-PD1 FDC)
Oncology Hematology Cell Therapy Immunology Cardiovascular Opdualag (anti-LAG3 + anti-PD1 FDC) Indication Adjuvant Melanoma 1L Melanoma SC 2L/3L+ MSS mCRC Phase/Study Phase III – RELATIVITY-098 Phase III – RELATIVITY-127 Phase III - RELATIVITY-123 # of Patients N = 1050 N = 814 N = 700 • Relatlimab
Slide 37: Opdualag (anti-LAG3 + anti-PD1 FDC)
Oncology Hematology Cell Therapy Immunology Cardiovascular Opdualag (anti-LAG3 + anti-PD1 FDC) Indication 1L HCC 1L Stage IV NSCLC Phase/Study Phase I/II - RELATIVITY-106 Phase II - CA224-104 # of Patients N = 162 N = 420 • Nivolumab + relatlimab + bevacizumab Part I: • Nivolumab + placebo + bevaciz
Slide 38: repotrectinib (ROS1/NTRK)
Oncology Hematology Cell Therapy Immunology Cardiovascular repotrectinib (ROS1/NTRK) Indication ROS1 NSCLC & NTRK+ Solid Tumors Phase/Study Phase I/II – TRIDENT-1 # of Patients N = 500 Phase I: • Dose escalation; food-effect, dose escalation with food; & Midazolam DDI Phase II: Expansion cohorts • R
Slide 39: mezigdomide (CELMoD)
Oncology Hematology Cell Therapy Immunology Cardiovascular mezigdomide (CELMoD) Indication 2L+ MM 2L+ MM Phase/Study Phase III – SUCCESSOR-1 Phase III – SUCCESSOR-2 # of Patients N = 810 N = 575 • Mezigdomide 0.3, 0.6, 1.0 mg + bortezomib 1.3 mg/m2a + • Mezigdomide 0.3, 0.6, 1.0 mg + carfilzomib 56
Slide 40: iberdomide (CELMoD)
Oncology Hematology Cell Therapy Immunology Cardiovascular iberdomide (CELMoD) Indication 2L+ MM Post-Transplant Maintenance NDMM Phase/Study Phase III – EXCALIBER Phase III – EXCALIBER-Maintenance # of Patients N = 864 N = 1,216 • Iberdomide 1.0, 1.3,1.6 mg + daratumumab 1800 mg + dex 40 • Iberdomi
Slide 41: Reblozyl (Erythroid Maturation Agent)
Oncology Hematology Cell Therapy Immunology Cardiovascular Reblozyl (Erythroid Maturation Agent) 1L Myelodysplastic Syndrome (MDS) 1L TD Myelofibrosis (MF) Indication Associated Anemia Associated Anemia Phase/Study Phase III - COMMANDS Phase III - INDEPENDENCE # of Patients N = 362 N = 309 • Reblozy
Slide 42: Reblozyl (Erythroid Maturation Agent)
Oncology Hematology Cell Therapy Immunology Cardiovascular Reblozyl (Erythroid Maturation Agent) TD & NTD Alpha-Thalassemia 1L NTD Low-or Intermediate Risk Indication (Ex-US study) Myelodysplastic Syndrome (MDS) Associated Anemia Phase/Study Phase II - CA056-015 Phase III – ELEMENT-MDS # of Patients
Slide 43: Onureg (Hypomethylating Agent)
Oncology Hematology Cell Therapy Immunology Cardiovascular Onureg (Hypomethylating Agent) Indication (IPSS-R) Low-or Intermediate Risk MDS Phase/Study Phase II/III – METEOROID # of Patients N = 230 Part I: • Onureg 200 mg, 300 mg in Phase II + Best Supportive Care Design Part II: • Onureg RP3D in Ph
Slide 44: alnuctamab (BCMA x CD3 T-Cell Engager)
Oncology Hematology Cell Therapy Immunology Cardiovascular alnuctamab (BCMA x CD3 T-Cell Engager) Indication 4L+ MM Phase/Study Phase I - CC-93269-MM-001 # of Patients N = 220 Design • alnuctamab 10, 30, 60 mg SC Primary: Endpoints • RP2D • Safety and tolerability • Data presented at ASH 2022 Status
Slide 45: Breyanzi (anti-CD19 CAR T)
Oncology Hematology Cell Therapy Immunology Cardiovascular Breyanzi (anti-CD 19 CAR T) Indication R/R NHL R/R iNHL 3L+ CLL Phase/Study Phase I/II – TRANSCEND Phase II – TRANSCEND FL Phase II – TRANSCEND CLL # of Patients N = 385 N = 213 N = 209 • Breyanzi • Breyanzi • Breyanzi • Breyanzi + ibrutinib
Slide 46: Abecma (anti-BCMA CAR T)
Oncology Hematology Cell Therapy Immunology Cardiovascular Abecma (anti-BCMA CAR T) Indication 3L-5L MM NDMM with Suboptimal Response post-ASCT Phase/Study Phase III – KarMMa-3 Phase III – KarMMa-9 # of Patients N = 381 N = 618 • Abecma • Abecma followed by lenalidomide maintenance • Standard regime
Slide 47: cendakimab (anti-IL-13)
Oncology Hematology Cell Therapy Immunology Cardiovascular cendakimab (anti-IL-13) Eosinophilic Gastroenteritis (EGE) Indication Eosinophilic Esophagitis (EoE) (Japan study) Phase/Study Phase III - CC-93538-EE-001 Phase III - CC-93538-EG-001 # of Patients N = 399 N = 45 • Cendakimab 360 mg SC QW for
Slide 48: LPA1 antagonist
Oncology Hematology Cell Therapy Immunology Cardiovascular LPA1 antagonist Indication Idiopathic Pulmonary Fibrosis Progressive Pulmonary Fibrosis Phase/Study Phase III – IM027-068 Phase III – IM027-1015 # of Patients N = 1,185 N = 1,092 • LPA1 Dose 60 mg BID • LPA1 Dose 60 mg BID Design • LPA1 Dose
Slide 49: Sotyktu (TYK-2 inhibitor)
Oncology Hematology Cell Therapy Immunology Cardiovascular Sotyktu (TYK-2 inhibitor) Indication Psoriatic Arthritis (PsA) Phase/Study Phase III - POETYK-PsA-1 Phase III - POETYK-PsA-2 # of Patients N = 650 N = 700 52-week study of patients with active PsA in TNF-naïve patients 52-week study of patie
Slide 50: Sotyktu (TYK-2 inhibitor)
Oncology Hematology Cell Therapy Immunology Cardiovascular Sotyktu (TYK-2 inhibitor) Indication Systemic Lupus Erythematosus (SLE) Discoid Lupus Erythematosus (DLE) Sjogren's (SjS) Phase/Study Phase III - POETYK SLE-1 Phase III - POETYK SLE-2 Phase II - IM011-132 Phase III - POETYK SjS-1 # of Patien
Slide 51: Sotyktu (TYK-2 inhibitor)
Oncology Hematology Cell Therapy Immunology Cardiovascular Sotyktu (TYK-2 inhibitor) Indication Alopecia Areata (AA) Phase/Study Phase II – IM011-134 # of Patients N = 90 • Sotyktu Dose 1 • Sotyktu Dose 2 Design • Placebo, followed by Sotyktu Dose 1 or Dose 2 • Primary: Change from baseline in SALT
Slide 52: Zeposia (S1P agonist)
Oncology Hematology Cell Therapy Immunology Cardiovascular Zeposia (S1P agonist) Indication YELLOWSTONE Program: Crohn’s Disease (CD) - Moderate to Severe Phase III - RPC01-3201 Phase III - RPC01-3202 Phase III - RPC01-3203 Phase/Study (Induction 1) (Induction 2) (Maintenance) # of Patients N = 600
Slide 53: obexelimab (CD19 x FcγRIIB bifunctional mAb)
Oncology Hematology Cell Therapy Immunology Cardiovascular obexelimab (CD19 x FcγRIIB bifunctional mAb) IgG4-Related Disease Indication (ex-US study) Phase III – INDIGO Phase/Study Non-BMS Sponsored* # of Patients N = 200 • Obexelimab SC • Placebo SC Design • Primary: Time to first IgG4-RD flare tha
Slide 54: milvexian (FXIa inhibitor)
Oncology Hematology Cell Therapy Immunology Cardiovascular milvexian (FXIa inhibitor) Indication Secondary Stroke Prevention Acute Coronary Syndrome Non-Valvular Atrial Fibrillation Phase III – LIBREXIA-STROKE Phase III – LIBREXIA-ACS Phase III – LIBREXIA-AF Phase/Study Non-BMS Sponsored* Non-BMS Sp
Slide 55: Camzyos (myosin inhibitor)
Oncology Hematology Cell Therapy Immunology Cardiovascular Camzyos (myosin inhibitor) Indication Heart Failure with Preserved Ejection Fraction (HFpEF) Non-Obstructive Hypertrophic Cardiomyopathy (nHCM) Phase/Study Phase II - EMBARK Phase III - ODYSSEY-HCM # of Patients N = 35 N = 420 • Camzyos • Ca
Slide 56: Abbreviations
Abbreviations AA Alopecia Areata EoE Eosinophilic Esophagitis MTD Maximum Tolerated Dose RP3D Recommended Phase 3 Dose American Association for Cancer AACR ESA Erythropoietin Stimulating Agents MZL Marginal Zone Lymphoma ROS C-ROS Oncogene Research Adj Adjuvant ESCC Esophageal Squamous Cell Carcinom
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